Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer

Trial Information

Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer

OBJECTIVES: I. Determine the clinical benefit response (including improvement in quality of
life) of vinorelbine and paclitaxel in patients with metastatic hormone-refractory prostate
cancer. II. Correlate PSA response with clinical benefit response in these patients. III.
Determine the objective response rate and duration of remission in patients with measurable
disease treated with this regimen. IV. Further assess the toxicity of this combination in a
cohort of prostate cancer patients. V. Examine the survival characteristics of these
patients undergoing this regimen.

OUTLINE: This an open label study. Patients receive vinorelbine IV over 6-10 minutes on days
1, 2, and 3 and paclitaxel IV over 3 hours on day 3 following vinorelbine. Course repeats
every 28 days in the absence of disease progression or unacceptable toxicity. Quality of
life is assessed before each treatment course. Patients are followed until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study over 15-30 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate
that is hormone refractory Hormone-refractory defined as at least 50% increase in PSA
while continuing hormonal therapy Must have received prior hormonal manipulation including
either orchiectomy or LHRH agonist Must be symptomatic and on a stable dose of pain
medication No documented CNS involvement

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy No other concurrent chemotherapy Endocrine therapy: See Disease
Characteristics At least 4 weeks since prior antiandrogens If patients have received prior
antiandrogens, PSA levels are reassessed at 4 week intervals until there is no decrease in
PSA levels before registration into this study Radiotherapy: Prior radiotherapy allowed
Must have recovered from prior radiotherapy Concurrent radiotherapy for symptomatic bone
lesion allowed Surgery: Not specified Other: No other concurrent therapeutic study

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James D. Ahlgren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

George Washington University

Authority:

United States: Federal Government

Study ID:

CDR0000066701

NCT ID:

NCT00003622

Start Date:

January 1999

Completion Date:

Related Keywords:

Prostate Cancer

adenocarcinoma of the prostate

stage IV prostate cancer

recurrent prostate cancer

Prostatic Neoplasms

Name

Location

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